R WE ready for reimbursement? A round up of developments in real-world evidence relating to health technology assessment: part 11

Abstract

In this latest update we highlight a study from the REPEAT initiative that evaluates the reproducibility of real-world data studies, the publication of the HARPER Protocol Template developed by a joint ISPE/ISPOR taskforce, and discuss recent US FDA guidance on external control arms.

Keywords: FDA; HARPER; REPEAT; RWD; external control arms; protocols; real-world data; reproducibility; trial design.